BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 6244407 · Received January 11, 2017

    Report

    Report Number
    3004478276-2016-00189
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    June 8, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000436
    PMA / PMN Number
    P150011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE (PVS 25/L SN (B)(4)) WAS RECEIVED IN THE EXPLANT KIT IN THE ORIGINAL PLASTIC JAR AND IN GENERAL GOOD CONDITIONS THE COLLAPSING PROCEDURE WAS PERFORMED USING THE RETURNED VALVE PVS 25/L - SN (B)(4) AND A REPRESENTATIVE COLLAPSING EQUIPMENT. THERE WERE NO PROBLEMS IN POSITIONING THE VALVE RETURNED BUT THERE WERE DIFFICULTY IN COLLAPSING THE VALVE. IN PARTICULAR, THE INFLOW CAP WAS NOT CORRECTLY RECOVERED ON THE INFLOW SIDE AND, ON THE OUTFLOW SIDE, THE OUTFLOW METALLIC CROWN OF THE VALVE DIDN'T COLLAPSE CORRECTLY , THE GEOMETRY OF THE OUTFLOW SIDE DID NOT HAVE A CIRCULAR SHAPE DURING THE COLLAPSING. IN ORDER TO BETTER UNDERSTAND THIS SHAPE DEVIATION, A MEASURE OF THE ANGLE OF THE SINUSOIDAL STRUCTURE WAS PERFORMED WITH OGP INSTRUMENT. THE REVIEW OF THE MANUFACTURING AND QUALITY CONTROL DATA FILED IN THE DHR OF THE PERCEVAL S HEART VALVE PROSTHESIS PVS 25/L, CONFIRMED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THAT THE PROCESS WAS PERFORMED IN ACCORDANCE WITH LIVANOVA SPECIFICATIONS. THE VALVE SATISFIED ALL MATERIAL, DIMENSIONAL, AND PERFORMANCE STANDARDS REQUIRED FOR A SIZE 25/L PERCEVAL S HEART VALVES AT THE TIME OF MANUFACTURE AND RELEASE. THE DOCUMENT REVIEW CONFIRMED THAT THE PVS 25/L - SN A(B)(4), SATISFIED ALL REQUIREMENTS AT THE TIME OF MANUFACTURE AND RELEASE. THE COLLAPSING PROCEDURE PERFORMED WITH THE RETURNED VALVE AND A REPRESENTATIVE COLLAPSING EQUIPMENT HAS HIGHLIGHTED THE INCORRECT SHAPE OF THE OUTFLOW CROWN ( AS SHOWN BY THE OGP MEASUREMENTS) : THIS COLLAPSING ISSUE OF THE PERCEVAL VALVES FOR SIZES L, WAS ALREADY DEEPLY EXAMINED IN LIVANOVA IN THE COURSE OF CORRECTIVE AND PREVENTIVE ACTION ((B)(4)) WHERE ACTIONS TO AVOID RECURRENCE OF ANOMALOUS STENT GEOMETRY HAVE BEEN IMPLEMENTED. THE VALVE OBJECT OF THIS COMPLAINT WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS ACTION. PLEASE NOTE THAT FOR METHODS- DIMENSIONAL ANALYSIS WAS ALSO PERFORMED, THE MANUFACTURER CAN NOT FIND SUITABLE CODE TO REFLECT THIS ACCORDING TO GUIDELINES, AND THEREFORE IS LISTING AS PART OF THE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS ON FEB 2, 2017. GROSS EXAMINATION WAS PERFORMED ON (B)(6) 2017. ON (B)(6) 2017, THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL HEART VALVE, MODEL ICV1210, S/N #(B)(4), WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A PERCEVAL PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. VISUAL INSPECTION WAS COMPLETED FEB 8, 2017: ACCORDING TO THE PROCEDURE (CURRENT REVISION). THE INSPECTION WAS DONE WITH THE PROCEDURE CONSIDERING THE NEW SEAM STENT/ PERICARDIUM - WHITE STITCHING. THE FREE MARGIN IS OK . THE LEAFLET ARE ABOVE THE PROFILE OF THE TEMPLATE, ACCEPTABLE ACCORDING TO THE PROCEDURE (PREVIOUS AND CURRENT REVISION). THERE WERE NO OTHER DEFECTS.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON 13-DEC-2016 OF THE FOLLOWING: THE SURGEON HAD DIFFICULTY WITH A PERCEVAL VALVE WHILE HE WAS PERFORMING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2016 IT IS WAS CLARIFIED THAT THE VALVE COULD NOT BE COLLAPSED COMPLETELY AND SYMMETRICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25754 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. PVS25 00896208000436

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization